DURATION OF ABSOLUTE PROTEINURIA RESPONSE WITH NEFECON IN PATEINTS WITH PRIMARY IMMUNOGLOBULILN A NEPHROPATHY: RESULTS FROM THE 2-YEAR NEFIGARD TRIAL - International Society of Nephrology Events

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https://storage.unitedwebnetwork.com/files/1099/a4bfaebeac5ded902ce46bfde9871537.pdf

Abstract Title *

DURATION OF ABSOLUTE PROTEINURIA RESPONSE WITH NEFECON IN PATEINTS WITH PRIMARY IMMUNOGLOBULILN A NEPHROPATHY: RESULTS FROM THE 2-YEAR NEFIGARD TRIAL

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Presenter First Name

Brad

Presenter Surname

Rovin

Co-author 1

Brad Rovin brad.rovin@osumc.edu Ohio State University Wexner Medical Center Nephrology Columbus United States *

Co-author 2

Heather Reich heather.reich@uhn.ca University Health Network Medicine Toronto Canada -

Co-author 3

Richard Lafayette czar@stanford.edu Stanford University Medicine Standford United States -

Co-author 4

Russel Jones russell.jones@calliditas.com Calliditas Therapeutics Therapeutics Stockholm Sweden -

Co-author 5

Jonathan Barratt jb81@leicester.ac.uk University of Leicester Life Sciences Leicester United Kingdom -

Co-author 6

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Co-author 7

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Co-author 9

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Co-author 10

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Introduction

Proteinuria reduction is a surrogate marker of improved kidney outcomes in immunoglobulin A nephropathy (IgAN). The Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines for IgAN recommend absolute proteinuria of <0.5 g/day as a treatment goal (guidelines at the time the NefIgArd trial was initiated recommended an absolute proteinuria target of <1.0 g/day). Data from the 2-year placebo-controlled NefIgArd trial have shown sustained relative reductions in the urine protein−creatinine ratio (UPCR) from baseline with nefecon, a targeted-release budesonide formulation, in patients with IgAN (Barratt J, et al. ERA 2025 [abstract 2651]). Here, we present NefIgArd data evaluating the effect of nefecon vs placebo on sustained absolute proteinuria response.

Methods

In this Phase 3 trial, adults with IgAN, estimated glomerular filtration rate (eGFR)
35-90 mL/min/1.73 m2 and UPCR ≥0.8 g/gram despite optimized renin–angiotensin system inhibition (RASi), were randomized to receive nefecon 16 mg/day or placebo for 9 months, followed by 15 months off treatment. Optimized RASi was maintained throughout. Proportions of patients maintaining an absolute UPCR response, defined as UPCR ≤1 g/gram, for ≥6, ≥9, ≥12, and ≥18 months were determined.

Results

In this Phase 3 trial, adults with IgAN, estimated glomerular filtration rate (eGFR)
35-90 mL/min/1.73 m2 and UPCR ≥0.8 g/gram despite optimized renin–angiotensin system inhibition (RASi), were randomized to receive nefecon 16 mg/day or placebo for 9 months, followed by 15 months off treatment. Optimized RASi was maintained throughout. Proportions of patients maintaining an absolute UPCR response, defined as UPCR ≤1 g/gram, for ≥6, ≥9, ≥12, and ≥18 months were determined.

Conclusion

Almost three-quarters of nefecon-treated patients maintained UPCR at or below 1 g/gram for at least 9 months, and almost half for at least 18 months. These data show that nefecon treatment enables a substantial proportion of patients to achieve absolute target proteinuria levels of below 1 g/gram for sustained periods. This is an encore submission from the American Society of Nephrology 2026 meeting.

Kewords